JJUA55069U European Pharmaceutical
Law, IPR & the Life Sciences – from research to market
approval, commercialization and distribution

This course intends to give students a deep understanding of a
variety of legal issues that are crucial to the pharma and life
science sectors before and after their products have received
market approval (MA) by the relevant authorities. It is a
comprehensive and practical course for students with an interest in
the legal aspects of the pharmaceutical and biomedical industry.
Besides providing students with the necessary theoretical
knowledge, this course entails a unique opportunity to gain
practical insights both through practitioner-lectures and field
trips to law firms and companies in the Medicon Valley. It is
targeted towards students that consider a career in life sciences -
be it as in-house counsel with a pharmaceutical/life science
company or as a legal expert at a consulting firm or in relevant
agencies and organizations. Due to the great variety of legal
aspects covered, the course will be relevant also for students with
a general interest in IP, EU law, biomedical law, international and
comparative law or public policy. In order to understand how these
legal aspects influence the pharmaceutical industry in the context
of rapid legal, political, economic and scientific changes, it is
important to gain an understanding of the business dynamics of the
industry and some basic knowledge of drug development and the
science on which it is based. Against this background, the course
is designed to provide students with a broad and practical
understanding of the industry and various legal disciplines that
affect it by presenting them around their importance to each step
in the lifecycle of a pharmaceutical product – from research and
invention to market approval, commercialization and distribution.
The focus is on substantive legal issues at an EU level, rather
than at the national level. Students will read and discuss
real-life scenarios aimed at developing analytical thinking and
reflective judgment. On the pre-MA stage the course will address
the regulation of research & development, the protection of
inventions stemming from areas such as stem cell research,
gene-technology and personalized medicine, through patents, SPCs
and regulatory exclusivities, as well as the regulatory framework
related to the MA procedure. On the post MA level special emphasis
will be laid on patent litigation, technology transfer &
licensing, regulatory rules related to pharmacovigilance and
product safety, the marketing of pharmaceutical products, parallel
trade, competition law and access to medicine. More specifically,
the course will be taught in 18 lectures of 3 hours each, including
Q & A lectures. It will thus comprise 54 hours of teaching.
The lectures are divided into eight main- segments reflecting the
typical chronological stages of pharmaceutical product development
and commercialization:
• Part I provides the students with a basic scientific
preface and a first overview of the business environment, the legal
landscape and the most central issues that will be addressed
throughout the course.
• Part II will deal with selected legal aspects of
research regulation.
• Part III will address the protection of research results
through patents and SPCs. We will concentrate on the most important
patentability requirements and discuss their application vis-à-vis
pharmaceutical, biotech and life science inventions during the
patent prosecution procedure.
• Part IV will focus on specific regulatory aspects and the
legal procedure for conducting clinical trials and securing
marketing approval.
• Part V will deal with selected legal aspects that will
have to be considered after a pharmaceutical product has received
market approval, including topics such as pharmacovigilance,
product safety regulations, pricing, transparency and ethical
problems, as well as legal issues related to advertising and
marketing/promoting the product.
• Part VI will focus on post grant IPR litigation, including
the process and considerations regarding the enforcement of
patents/SPC rights and regulatory data and marketing exclusivities.
This part will also address technology transfer and licensing
issues.
• Part VII addresses the interface between IPRs with EU
competition law and general EU, for example in the context of
pharmaceutical patent settlements and parallel trade.
• Finally part VIII will deal with the debates related to
compulsory licensing and access to medicine in both the “developed”
and developing world.

The basic learning outcomes that shall result from the course
are fundamental to the understanding of the subject and therefore
generally apply to BA students. All students will be
expected to contribute actively to class-room discussions,
regardless of degree level. The assessment by oral examination,
however, will take into account the different expectations for
BA students.
Before this background the learning outcome of the course can be
defined as follows:
1) Knowledge: All students should acquire knowledge about
• the content, relevance and interrelationship of
specific legal disciplines, as well as basic scientific and
business aspects that are of particular importance to the
pharmaceutical industry
• the basic legal rules concerning the protection
and/or regulation of an object, subject and contents within the
pharmaceutical law disciplines
2) Skills: All students should acquire skills in
• presenting & explaining solutions and legal
arguments in a systematic and coherent manner that demonstrates
overview, as well as in-depth knowledge and understanding of
specific pharmaceutical law issues.
• identifying specific problems and legal arguments
within pharmaceutical law on the basis of complex material.
Master students should acquire additional skills in:
• discussing the pros and cons of applying the various
disciplines/solutions within complex problem areas.
• making academically reasoned arguments and decisions
for different solutions including a critical weighing of the legal
arguments and choices.
3) Competences: All students should acquire competences in:
• Critically reflect and put into perspective the
interdisciplinary differences and similarities of the legal and
scientific areas involved.
• Analyze to what extent identified problems can be
solved in practice by exploiting diverse legal disciplines and
arguments.
Master students should acquire additional competences in:
• combining different academic approaches, such as
legal methods of interpretation, in connection with the analysis.
• communicating and formulating the acquired knowledge
and arguments professionally and linguistically correct and in a
structured & coherent way.

• Folder of selected articles, cases, commentaries and reports.
Some of these will be made available through ABSALON, other will be
distributed in class before each lecture.

Ca. 750 pp. in total

• 2. Optional readings - Additional cases and supplementary
materials - selected and made available by the teachers - These are
optional readings for students that want to dwell deeper into the
issues.

As stated in the
course-content, this course intends to give students a deep
understanding of a variety of legal issues that are crucial to the
pharma and life science sectors before and after their products
have received market approval by the relevant
authorities.

The course method is to go
beyond passive listening; interaction, group work, case studies and
student-presentations are an essential part of the class. Field
trips into the pharmaceutical industry, law firms and authorities,
group discussions and presentations will be structured around
introductory or explanatory lectures. Material provided in the
classroom and as preparatory reading will consist of newspaper
articles, research papers, reports, and case law.

-The students will be
divided into groups. Each group is expected to present cases that
will be discussed in class.
- Reasonable understanding of English is mandatory
- The teachers will make intensive use of ABSALON. The students
should therefore be well acquainted with the system.
- Further internal and external teachers might be involved in due
course.
- Field trips to major pharmaceutical companies and law firms are
an option.
- Basic skills in European law are recommended.
- Lawyers or scientists who have just started to practice in the
pharmaceutical sector and want get a better understanding of the
area can be accepted after payment of a fee specified and
determined by the University.
- Specific topics and legal developments of major practical
relevance might be developed further and be marketed in the form of
practitioner seminars. More information is available at :
http:/​/​jura.ku.dk/​pdf/​uddannelsesservice/​fag_kurser/​kandidat/​Supp_Info__European_Pharma.pdf/​
(This document will be updated before the start of the
course)

It is one of the objectives of the course to equip students with
the ability to engage in academic discussions and to be able to
present and explain legal challenges. It is therefore mandatory to
prepare one short in class-presentation of a selected case or
problem area.

Marking scale

7-point grading scale

Censorship form

External censorship

Exam period

Autumn: December 12 - 16, 2016 (preliminary dates)

Spring: May 29 - June 2, 2017 (preliminary dates)

Re-exam

Please see "Academic calendar" on KUnet.

Criteria for exam assesment

The objective of the examination is to determine the extent to
which the students have acquired the knowledge and competencies,
which are defined in the learning objectives of the course.
The exam will be closely linked to this course-plan and the content
of the actual lectures, as the students focus on the material they
must master at the exam during their study activity and learning
process.
Before this background the students are evaluated by:
- their knowledge of the applicable law and procedures
- their skills in identifying, presenting & explaining
solutions and legal arguments in a systematic and coherent manner
- their ability/competence to analyze and discuss how the
identified problems could/should be solved in practice by
exploiting diverse legal disciplines and arguments More specific
information on the scope and the precise topics of the examination
will be provided in the Q&A lectures.
As indicated in the description of the learning outcomes the
evaluation of the students will also depend on if the students are
participating on the bachelor or master
level.